Avita starts EU study for leg ulcer spray

20 Nov 2012, BioSpectrum Bureau , BioSpectrum

Singapore: Regenerative medicine company, Avita Medical, has initiated a multicenter randomized control study on the use of ReCell Spray-On Skin for the treatment of venous leg ulcers. Up to five European centers from countries including the UK, Germany, France and Denmark will participate in the study.

Lower limb ulcers (LLUs), which include venous leg ulcers and diabetic foot ulcers, are a major healthcare problem in developed countries due to their prevalence, high cost of treatment and significant impact on patient quality of life. LLUs afflict nearly 1.5 percent of the general population in OECD countries alone. The costs that the patients need to incur include lost work days and wages along with associated morbidity, pain and lack of mobility.

In preliminary open-label studies ReCell was used at four European centers to treat approximately 80 patients suffering from venous leg ulcers and diabetic foot ulcers. Across study centres patients' average age was approximately 70 years, wounds were open an average of approximately 13 months and averaged approximately 21 square centimeter in size.

Results of these preliminary studies show that over 70 percent of patients completely healed the wound within seven-to-12 weeks following a single treatment with ReCell. With the current standard-of-care treatment it would be expected that approximately 43 percent of these wounds would have achieved closure during this period, thus ReCell appears to yield a highly significant positive effect on wound healing. Pain, a critical indicator of quality of life, was reported as being significantly reduced or eliminated within 72 hours following the ReCell treatment.

Dr William Dolphin, CEO, Avita Medical, said that, "ReCell is approved for use in Europe, Australia and other markets with over 4,500 procedures conducted until date, mainly for burns. Improved leg ulcer treatment will provide tremendous relief for ulcer patients, potentially deliver significant cost savings to financially stressed healthcare systems and open very large markets for ReCell."